September 1, 2019
BIOSTEMI Trial Compares Biotronik's Orsiro Bioresorbable SES Versus Abbott's Xience Durable EES in STEMI Patients
September 2, 2019—Biotronik announced the presentation of data from the BIOSTEMI randomized controlled trial by Principal Investigator Juan Fernando Iglesias, MD, during a late-breaking session at the European Society of Cardiology’s 2019 congress held August 31–September 4 in Paris, France. The results were also published in The Lancet.
BIOSTEMI is an investigator-initiated, multicenter, superiority trial using a Bayesian design to compare biodegradable polymer sirolimus-eluting stents (SESs) to durable polymer everolimus-eluting stents (EESs) in 1,300 patients with acute myocardial infarction.
In the BIOSTEMI trial, the company’s ultrathin Orsiro biodegradable polymer SES demonstrated superiority over the Xience durable polymer EES (Abbott) with respect to target lesion failure (TLF) at 12 months in patients with acute ST-segment elevation myocardial infarction.
According to Biotronik, Orsiro demonstrated superiority in the clinical primary endpoint of TLF with an incidence of 4%, in comparison to Xience with an incidence of 6% at 12 months (rate ratio, 0.59; 95% Bayesian credible interval, 0.37–0.94; posterior probability of superiority, 98.6%). The difference in TLF was driven by lower rates of clinically indicated target lesion revascularization in patients treated with the ultrathin Orsiro compared to Xience.
Dr. Iglesias, who is from Geneva University Hospitals in Geneva, Switzerland, commented in the company’s announcement, “The BIOSTEMI trial proves what the BIOSCIENCE STEMI subgroup analysis had already suggested: different platform designs can really make a difference. Based on the data, compared to the Xience stent, Orsiro is a superior solution for STEMI patients. In this patient group, vascular healing is a challenge due to the complex prothrombotic and inflammatory milieu. With Orsiro, we can incrementally improve their care path.”